This study is researching an experimental drug called linvoseltamab. The study is focused on participants with newly diagnosed multiple myeloma (NDMM) who are ineligible for autologous stem cell transplantation (transplant-ineligible).
The main purpose of this study is to compare the effect and safety of linvoseltamab with the effect and safety of the standard treatment.
Participants must have confirmed diagnosis of symptomatic MM per IMWG criteria.
Participants must not be considered a candidate for high-dose chemotherapy (HDT) and ASCT, as described in the protocol.
Participants must have measurable disease as defined in the protocol.
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
International Myeloma Working Group Frailty Index of 2 with the exception of participants who have a score of 2 based on age alone.
Participants who defer transplant due to personal preference.
Participants with non-secretory MM, active plasma cell leukemia, known light-chain (AL) amyloidosis in the presence of a concurrent diagnosis of myeloma, any other form of amyloidosis, Waldenström macroglobulinemia, or known POEMS syndrome.
focal radiation and/or
Parallel
Linvoseltamab
DrugAdministered per the protocol
Daratumumab
DrugAdministered per the protocol
Lenalidomide
DrugAdministered per the protocol
Dexamethasone
DrugAdministered per the protocol
Minimal Residual Disease (MRD)
Minimal Residual Disease (MRD) negative Complete Remission (CR) status at 10\^-5 per International Myeloma Working Group (IMWG) criteria
MRD negative CR status by BICR
MRD negative CR status at 10\^-5 as determined by the Blinded Independent Central Review (BICR)
Progression Free Survival (PFS) per IMWG criteria
defined as the time from the date of randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier, where disease progression is determined per IMWG criteria.
PFS as determined by BICR
defined as the time from the date of randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier, where disease progression is determined per by BICR.
Overall Survival (OS)
Overall Survival (OS), measured from the date of from randomization to the date the subject's death
Objective Response (OR) of Complete Response (CR)
To compare the proportion of patients who achieve an objective response per International Myeloma Working Group (IMWG) response criteria between the two study arms for Complete Response (CR) or better
OR of Very Good Partial Response (VGPR)
To compare the proportion of patients who achieve an objective response per International Myeloma Working Group (IMWG) response criteria between the two study arms for VGPR or better
OR of Partial Response (PR)
To compare the proportion of patients who achieve an objective response per International Myeloma Working Group (IMWG) response criteria between the two study arms for PR or better
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European Myeloma Network B.V.
Lead sponsor
Regeneron Pharmaceuticals
Collaborator
